Drug Interactions between alpelisib and pamidronate

MONITOR: Coadministration of alpelisib with bisphosphonates or denosumab may increase the risk of developing osteonecrosis of the jaw (ONJ). The condition can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing, particularly in the presence of other risk factors including cancer, chemotherapy, radiotherapy to the head and neck, poor oral hygiene, preexisting dental disease or infection, anemia, or coagulopathy.

MANAGEMENT: Caution is advised when alpelisib is used simultaneously or sequentially with bisphosphonates or denosumab. Treatment should not be initiated in patients with ongoing ONJ from previous or concurrent treatment with bisphosphonates or denosumab. A routine oral examination should be performed by the prescriber prior to initiation of alpelisib treatment. For patients requiring invasive dental procedures, clinical judgment and risk-benefit assessment should guide the management plan of each patient based on their clinical circumstances. Patients should be advised to seek medical attention if they experience signs and symptoms of ONJ, such as: pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw; loosening of a tooth; or exposure of bone in the jaw. Standard medical management should be initiated in patients who develop ONJ.